A Randomised, Double-blind, Placebo-controlled 4-period Cross-over Study to Assess the Efficacy and Safety of Repeat Dose Intranasal GSK1004723 (1000µg), Oral GSK835726 (10mg) and Cetirizine (10mg) in the Environmental Challenge Chamber in Subjects With Seasonal Allergic Rhinitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3
研究概览
简要总结
This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
- •Males or female using contraceptives
- •Aged 18 - 65
- •Weight 50kg+, BMI 19-32 kg/m2
- •Exhibit response to Challenge Chamber and skin prick test.
- •Non-smoker
- •Capable of giving informed consent
- •AST and ALT<2xULN; alkaline phosphatase and bilirubin <or=1.5xULN
排除标准
- •No nasal structural abnornmality/polyposis, surgery, infection.
- •any respiratory disease, other than mild asthma or seasonal allergic rhinitis
- •participated in another clinical study within 30 days.
- •Subject has donated a unit of blood within 1 month
- •Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
- •History of sensitivty to drug
- •History of alcohol/drug abuse within 12 months.
- •Positive Hepatitis B antibody test
- •Positive HIV antibody test
- •Risk of non-compliance with study protocol
- •Pregnant or llactating females
- •Perenial allergic rhinitis
- •Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
- •Past or present disease that may affect outcome, as judge by investigator
- •Specific Immunotherapy within 2 years
研究组 & 干预措施
GSK835726 (10mg)
10mg oral dose
干预措施: GSK835726 10mg (Drug)
GSK1004723 (1000mcg)
1000mcg nasal spray solution
干预措施: GSK1004723 1000mcg (Drug)
Cetirizine 10mg
10mg cetirizine as active comparator
干预措施: Cetirizine 10mg (Drug)
placebo
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3
时间窗: Day 3 of each treatment period (approximately up to 63 days)
On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean.
次要结局
- Mean Forced Expiratory Volume in 1 Second (FEV1)(Day 3 of each treatment period (approximately up to 63 days))
- Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3(Day 3 of each treatment period (approximately up to 63 days))
- Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3(Day 3 of each treatment period (approximately up to 63 days))
- Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3(Day 3 of each treatment period (approximately up to 63 days))
- Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)(approximately up to 63 days)